The purpose of this clinical study is to evaluate the preliminary safety and feasibility of using the VALSE system, which combines spinal cord stimulation with the TWIICE robotic exoskeleton, to support motor recovery and reduce reliance on laboratory-based equipment during rehabilitation in participants with traumatic spinal cord injury. The TWIICE exoskeleton is integrated through the NR system, a platform developed by EPFL. The goal is to assess the clinical safety and practical application of this combined neuroprosthetic approach in a small number of participants, in order to guide future refinements of the device and protocol, support the development of scalable interventions integrating spinal stimulation with robotic assistance, and inform strategies for delivering rehabilitation in more accessible, real-world environments.
Currently enrolled participants who have completed the relevant phase of their parent study at CHUV: BoxSwitch (NCT05942339, after the optimisation phase), Think2Go (NCT06243952, after the rehabilitation phase, or STIMO-BSI (NCT04632290, after the calibration and training phase of the optional extension with system upgrade),
Must have a functional neuromodulation system,
Must be at least 18 years old,
Must be suffering from non-progressive traumatic spinal cord injury, sustained at least 12 months before signing the consent form,
Must not have deep vein thrombosis in lower extremities within the past 6 months.
Must not have experienced lower extremity fractures within the last two years.
Must not have current pressure ulcer of the arms, trunk, pelvic area, or lower extremities
Must not present with a flexion contracture >15° at the hip or knee
Single group
TWIICE Rise 1.0 robotic exoskeleton combined with epidural electrical stimulation (EES)
Combination productParticipants will use the VALSE system, which combines the TWIICE Rise 1.0 robotic exoskeleton with epidural electrical stimulation (EES) delivered through previously implanted neuromodulation systems. The system is intended to support upright mobility and overground walking in individuals with chronic spinal cord injury (SCI) who are currently enrolled in, or have completed key phases of, neuromodulation clinical trials at CHUV, including Think2Go (NCT06243952), STIMO-BSI (NCT04632290), and BoxSwitch (NCT05942339). The TWIICE exoskeleton provides robotic gait assistance, while EES facilitates activation of spinal motor circuits below the level of injury. Exoskeleton movements are initiated and controlled through participant-generated inputs, including finger-click commands and, where applicable, brain-derived control signals from previously implanted brain-spine interface systems. The VALSE system is used in supervised clinical and controlled real-world.
Preliminary safety
Occurrence of Serious Adverse Events (SAE) and Adverse Events (AE) that are deemed related or possibly related to the procedure or to the TWIICE exoskeleton in combination with the neuromodulation therapies (VALSE system)
Assessment of the experimental session conditions
Location and type of ground walked on.
Number of steps
Total number of steps recorded by the exoskeleton during each experimental (EX) session.
Step frequency
Average step frequency (cadence) recorded by the exoskeleton during each experimental (EX) session.
Mid-stride pauses
Number of mid-stride pauses recorded by the exoskeleton during each experimental (EX) session.
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Ecole Polytechnique Fédérale de Lausanne
Lead sponsor
Centre Hospitalier Universitaire Vaudois
Sponsor institution
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